14 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AssureTech Panel Dip Test, AssureTech Quick Cup Test
FDA 510(k)
FDA Class 2
·Clinical Toxicology
REUSABLE LINEAR STAPLER HANDLE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CUSA EXCEL 36KHZ DISPOSABLE WRENCH
FDA Adverse Event
Malfunction
·INTEGRA LIFESCIENCES (IRELAND) LTD.·Product code LFL·February 12, 2018
HEARTWARE® VENTRICULAR ASSIST SYSTEM
FDA Adverse Event
Malfunction
·HEARTWARE, INC·Product code DSQ·October 14, 2014
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·July 20, 2011
SURGIPRO II 6/0 24 BLUE KV-11 D/A
FDA Adverse Event
Death
·COVIDIEN, FORMERLY US·Product code GAW·June 4, 2013
ACE LINR- E-POLY HIGH-36/54 IMPLANT
FDA Adverse Event
Injury
·MAKO SURGICAL CORP.·Product code OQG·May 12, 2015
MAGNETOM Skyra fit. Model Number: 10849580.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·August 29, 2025
GMK-REVISION TIBIAL AUGMENTATION SIZE 2/10MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KRO·June 23, 2023
GMK-HINGE FEMORAL COMPONENT SIZE 2 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KRO·February 7, 2022
GMK-REVISION FIXED TIBIAL TRAY CEMENTED SIZE 3 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·August 29, 2019
GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/10MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·December 4, 2019